gudid
Primary ID: 5.014
Vivos DNA (UDI 5.014)
Manufactured by Aurum Group Ltd
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Vivos DNA - Primary ID 5.014
Device Regulatory Overview
The Vivos DNA (Model/Catalog Number: 5.014) is a medical device manufactured by Aurum Group Ltd. This product is indexed under FDA Product Code / Category Classification LRK within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 5.014
- Product Code / EMDN
- LRK
- Device Name
- The Vivos appliance is an adult palate expander used to treat adults who clench their teeth, have TMJ pain, and sleep apnea.
- Database Sync Date
- 2026-08-09 09:09:51
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Vivos DNA?
The registered manufacturer of record for Vivos DNA is Aurum Group Ltd.
What is the Primary UDI-DI identifier for Vivos DNA?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5.014.
What classification code is assigned to this device?
This device is registered under product classification code LRK.
Similar Classification Devices (LRK)
Other Devices by Aurum Group Ltd
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint